FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3 RING ATTACHMENT
K Number: K864555
·
Decision Dec 1, 1986
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
19
Review Days
12
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- 3 RING ATTACHMENT
- K Number
- K864555
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Professional Medical Services
- Date Received
- November 19, 1986
- Decision Date
- December 1, 1986
- Product Code
- FMF
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMF), ordered by most recent decision date.
Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle
FDA 510(k)
FDA Class 2
·General Hospital
Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
FDA 510(k)
FDA Class 2
·General Hospital
Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)
FDA 510(k)
FDA Class 2
·General Hospital
Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Instylla Delivery Kit
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Professional Medical Services
| K Number | Device Name | ||
|---|---|---|---|
| K913094 | DISPOSABLE SLIDE VALVE MANIFOLD | Jan 27, 1992 | Substantially Equivalent |
| K910378 | PRESSURE MONITORING EXTENSION LINE | Apr 22, 1991 | Substantially Equivalent |
| K904508 | CONDOR ANALOG INFLATION SYRINGE | Apr 2, 1991 | Substantially Equivalent |
| K904954 | CONDOR DIGITAL INFLATION SYRINGE | Jan 16, 1991 | Substantially Equivalent |
| K902606 | RADIOPAQUE RULER | Sep 27, 1990 | Substantially Equivalent |
| K884577 | PROCEDURE READY TRAYS | Aug 1, 1989 | Unknown |
| K890471 | PMS ANGIO DRAPE | Feb 27, 1989 | Substantially Equivalent |
| K884497 | CONTROL SYRINGE | Dec 12, 1988 | Substantially Equivalent |
| K872448 | BLOOD CONTAINMENT PACK | Nov 17, 1987 | Substantially Equivalent |
| K854941 | PMS PERCUTANEOUS PUNCTURE NEEDLE | Apr 16, 1986 | Substantially Equivalent |